Job Description The job that makes possibilities real in patients' lives. And yours. The job that helps you get ahead in life. Moving mountains together. Welcome to AbbVie As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place Moving mountains together – as Senior Scientist I / Senior Scientist II (all genders) Product Development Science & Technology (PDS&T) - Global Material and Parenteral Packaging Sciences (permanent) (full- or part-time) We are seeking a Senior Scientist to support the Global Material and Parenteral Packaging Science team within Product Development Science & Technology (PDS&T) for New Biologic Entities (NBE). Compatibility evaluation of a (bio)pharmaceutical drug substances (DS) and drug products (DP) with manufacturing process as well as packaging materials is a key element within the development process and during life cycle management of (bio)pharmaceuticals. Therefore, gaining in depth scientific insights regarding the interaction between process or container closure materials and the DS/DP is a prerequisite to ensure product quality and patient safety. The candidate will be working on the development of container closure systems (CCS) and manufacturing processes within the PDS&T organization at AbbVie. The focus of the position will be on scientific investigations of interactions between the DP and so called Extractables & Leachables (E&L) which can originate from process and packaging components. Additionally, the candidate will work on the evaluation, development, and characterization of established and innovative CCS for AbbVie’s parenteral drug product pipeline projects. This includes initiation, coordination, and scientific oversight for analytical activities at AbbVie and third-party laboratories (TPLs) according to compendial requirements and applicable guidelines. In addition, the candidate should scientifically drive innovations in the E&L field by actively contributing to internal as well as external consortia. The position will involve a combination of laboratory experimental work, documentation, project management, and a high level of interaction with cross functional project teams, suppliers, and TPLs. Responsibilities Lead, design, and evaluate the development of innovative materials and/or alternate packaging materials, packaging solutions or packaging systems for sterile dosage forms with focus on E&L and compatibility Expert Knowledge regarding E&L evaluation of container closure system (CCS)/process equipment materials for sterile parenteral pharmaceutical and biopharmaceutical products according to external regulatory requirements (e.g. USP and, ISO10993, ICHQ3D) Provide scientific advice for E&L evaluations for process equipment (e.g. disposables) and CCS development Provide assistance for quality and regulatory activities including preparation of technical documents for regulatory filings Management and exchange of scientific knowledge on E&L and CCS/process equipment characterization in general within AbbVie globally and external benchmarking Prepare and review comprehensive scientific and technical documents, including E&L study protocols and reports, validation protocols and reports, analytical test procedures, development reports, design history files and documents for CMC submissions